The invention relates to a gastrostomy device which is designed to be inserted through an opening in the wall of the abdomen and stomach of a patient for use in supplying nutrients and other fluids, including medication, into the stomach. Also, such a device can be used for decompression, and provides access for examination endoscopically, for example, using fiber optics. Other uses requiring insertion of a tube into other viscera for the body may be made of the device, such as bladder drainage, illeostomy, jejunostomy, colostomy, and cystostomy.
Certain medical conditions require the long term access for such purposes as internal feedings and/or medication to a person's stomach or other viscera of the body. This may be accomplished by inserting a tube through a surgical opening into the stomach or other viscera. Various devices have been used for this purpose.
U.S. Pat. Nos. 4,311,148 and 4,668,225 show feeding tubes or catheters having resilient wing-like protrusions about the end of the tube for retaining the tubes within a passage through the wall of a body cavity. The tubes are designed to be inserted into the patient through fresh incisions that are then sutured about the tube. To remove these tubes from the cavity it is possible to pull the end through the passage while exerting sufficient force to fold the wings back out of the way.
U.S. Pat. No. 4,573,576 shows a catheter with a disk-like retainer on one end. A line is introduced through an incision in the patient's skin, fascia and stomach wall and an endoscope used to capture the loose end within the stomach and to draw it out the patients's mouth. The line is then used to draw the tube portion of the catheter out through the incision. An endoscope is also used to remove the catheter.
After an incision establishes a passage through the body wall and a tube is passed therethrough, over a period of time the body heals to a degree about the tube. The passage or stoma becomes relatively stable, much like the hole for pierced ears for example. Without the tube it would eventually close up, but in the meantime, a well-defined passage exists even if the tube is withdrawn.
This well-defined passage is suitable for the external percutaneous insertion of appropriately designed catheters. However, none of the aforementioned devices are suitable for this purpose largely because of the difficulty in pushing a flexible tube versus pulling it and also because the folded-over wings make a poor dilator for the passage.
U.S. Pat. No. 4,863,438 which is included herein in its entirety by reference, shows a catheter that may be inserted into the stoma from outside the body. A hollow mushroom-shaped resilient head on the tube may be distended by the insertion of a rigid obturator into the tube, the distended head acting as a dilator small enough to pass through the stoma. Once the head clears the stoma, the obturator is withdrawn and the head expands. A similar process is employed to remove this device, or mechanical traction may be used to remove the device.
While unlike the other devices, this device may be inserted into an established stoma from outside the body, it is relatively difficult and expensive to manufacture because the head of the device is hollow. This necessitates either at least a two-piece construction or a much more expensive molding process.